On September 23, 2014, an Italian court in Milan award compensation to a boy for vaccine-induced autism. (See the Italian document here.) A childhood vaccine against six childhood diseases caused the boy’s permanent autism and brain damage.
While the Italian press has devoted considerable attention to this decision and its public health implications, the U.S. press has been silent.
Italy’s National Vaccine Injury Compensation Program
Like the U.S., Italy has a national vaccine injury compensation program to give some financial support to those people who are injured by compulsory and recommended vaccinations. The Italian infant plaintiff received three doses of GlaxoSmithKline’s Infanrix Hexa, a hexavalent vaccine administered in the first year of life. These doses occurred from March to October 2006. The vaccine is to protect children from polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B. In addition to these antigens, however, the vaccine then contained thimerosal, the mercury-containing preservative, aluminum, an adjuvant, as well as other toxic ingredients. The child regressed into autism shortly after receiving the three doses.
When the parents presented their claim for compensation first to the Ministry of Health, as they were required to do, the Ministry rejected it. Therefore, the family sued the Ministry in a court of general jurisdiction, an option which does not exist in the same form in the U.S.
Court Decision: Mercury and Aluminum in Vaccine Caused Autism
Based on expert medical testimony, the court concluded that the child more likely than not suffered autism and brain damage because of the neurotoxic mercury, aluminum and his particular susceptibility from a genetic mutation. The Court also noted that Infanrix Hexa contained thimerosal, now banned in Italy because of its neurotoxicity, “in concentrations greatly exceeding the maximum recommended levels for infants weighing only a few kilograms.”
Presiding Judge Nicola Di Leo considered another piece of damning evidence: a 1271-page confidential GlaxoSmithKline report (now available on the Internet). This industry document provided ample evidence of adverse events from the vaccine, including five known cases of autism resulting from the vaccine’s administration during its clinical trials (see table at page 626, excerpt below).
Italian Government, Not Vaccine Maker, Pays for Vaccine Damages
As in many other developed countries, government, not industry, compensates families in the event of vaccine injury. Thus GSK’s apparent lack of concern for the vaccine’s adverse effects is notable and perhaps not surprising.
In the final assessment, the report states that:
“[t]he benefit/risk profile of Infanrix hexa continues to be favourable,” despite GSK’s acknowledgement that the vaccine causes side effects including “anaemia haemolytic autoimmune,thrombocytopenia, thrombocytopenic purpura, autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, haemolytic anemia, cyanosis, injection site nodule, abcess and injection site abscess, Kawasaki’s disease, important neurological events (including encephalitis and encephalopathy), Henoch-Schonlein purpura, petechiae, purpura, haematochezia, allergic reactions (including anaphylactic and anaphylactoid reactions),” and death (see page 9).
The Milan decision is sober, informed and well-reasoned. The Ministry of Health has stated that it has appealed the Court’s decision, but that appeal will likely take several years, and its outcome is uncertain.
Rimini: 2012 – Italian Court Rules MMR Vaccine Caused Autism
Two years earlier, on May 23, 2012, Judge Lucio Ardigo of an Italian court in Rimini presided over a similar judgment, finding that a different vaccine, the Measles-Mumps-Rubella vaccine (MMR), had caused a child’s autism. As in the Milan case, the Ministry of Health’s compensation program had denied compensation to the family, yet after a presentation of medical evidence, a court granted compensation. There, too, the Italian press covered the story; the U.S. press did not.
In that case, a 15-month old boy received his MMR vaccine on March 26, 2004. He then immediately developed bowel and eating problems and received an autism diagnosis with cognitive delay within a year. The court found that the boy had “been damaged by irreversible complications due to vaccination (with trivalent MMR).” The decision flew in the face of the conventional mainstream medical wisdom that an MMR-autism link has been “debunked.”
Italian Court Decisions Break New Ground in Debate Over Vaccines and Autism
Both these Italian court decisions break new ground in the roiling debate over vaccines and autism. These courts, like all courts, are intended to function as impartial, unbiased decision makers.
The courts’ decisions are striking because they not only find a vaccine-autism causal link, but they also overrule the decisions of Italy’s Ministry of Health. And taken together, the court decisions found that both the MMR and a hexavalent thimerosal- and aluminum-containing vaccine can trigger autism.
Italian Court Rulings Contradict Special U.S. Vaccine Court
These court decisions flatly contradict the decisions from the so-called U.S. vaccine court, the Court of Federal Claim’s Vaccine Injury Compensation Program. There, from 2007 to 2010, in the Omnibus Autism Proceeding, three decision makers, called Special Masters, found that vaccines did not cause autism in any of the six test cases, and one Special Master even went so far as to compare the theory of vaccine-induced autism to Lewis Carroll’s Alice in Wonderland.
The Italian court decisions contrast starkly with these U.S. cases based on similar claims.
Read the full story at Age of Autism.
About the Author
Mary Holland is Research Scholar and Director of the Graduate Legal Skills Program at NYU Law School. She has published articles on vaccine law and policy, and is the co-editor of Vaccine Epidemic: How Corporate Greed, Biased Science and Coercive Government Threaten Our Human Rights, Our Health and Our Children (Skyhorse Publishing, 2012)
Guest Post: Crack Down on Those Who Don’t Vaccinate?: A Response to Art Caplan
Dr. Art Caplan recently posted an editorial, “Liability for Failure to Vaccinate,” on this blog. He argues that those who contract infectious disease should be able to recover damages from unvaccinated people who spread it. If you miss work, or your baby has to go to the hospital because of infectious disease, the unvaccinated person who allegedly caused the harm should pay. Dr. Caplan suggests that such liability is apt because vaccines are safe and effective. He sees no difference between this situation and slip-and-fall or car accidents due to negligence. Arguing that “a tiny minority continue to put the rest of us at risk,” he suggests that public health officials can catch the perpetrators and hold them to account through precise disease tracing.
Dr. Caplan’s assertions to the contrary, vaccines are neither completely safe nor completely effective. In fact, from a legal standpoint, vaccines, like all prescription drugs, are “unavoidably unsafe.” [See, e.g., Bruesewitz v. Wyeth, 562 U.S. __ (2011).] Industry considered its liability for vaccine injury so significant that it lobbied Congress for the 1986 National Childhood Vaccine Injury Act, providing doctors and vaccine manufacturers almost blanket liability protection for injuries caused by federally recommended vaccines. [See Authorizing Legislation.] The liability risk was so serious that the federal government created a special tribunal under the 1986 Act, the Vaccine Injury Compensation Program, to pay the injured. Moreover, the Supreme Court in 2011 decided Bruesewitz v. Wyeth, prohibiting any individual from filing a civil suit for a defectively designed vaccine in any court in the country. Industry’s extraordinary protection against liability for vaccine injury does not correspond with glib statements, like those of Dr. Caplan, that vaccines are safe and effective. On the contrary, the law acknowledges that vaccines cause injury and death to some, with no screening in place to mitigate harm. Dr. Caplan notes that public health officials have “tried to debunk false fears about vaccine safety.” Yet the Institute of Medicine, one the country’s most prestigious health organizations, has acknowledged repeatedly that there are many known vaccine injuries, such as seizures from the measles-mumps-rubella vaccine, anaphylaxis from the meningococcal vaccine, and encephalitis from the varicella vaccine. Even more troubling than the identified injuries is the number of potential vaccine adverse effect relationships for which the evidence is not sufficient to either prove or disprove causality. [Committee to Review Adverse Effects of Vaccines, Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality (Kathleen Straton et al. eds., 2012).]
Dr. Caplan seems to suggest a peculiarly narrow kind of civil liability, allowing claims only by those who have been vaccinated and become sick against those who lawfully refused vaccination. What if a vaccinated person spreads disease? Presumably, she would bear no liability because she would not have been negligent. Yet vaccinated people do spread disease, as in the case of Tenuto v. Lederle Labs., 907 NYS.2d 441 (2010). Mr. Tenuto, a father, contracted paralytic polio from his infant daughter while changing her diaper after the infant had received the live virus oral polio vaccine. Although the vaccine protected the infant from polio, it exposed her father to disease through viral shedding, causing him severe, lifelong harm. Despite proven causation, industry litigated for over thirty years to avoid paying for the damages that occurred before the 1986 liability protections took effect.
And what if disease breaks out in a highly vaccinated population, with no unvaccinated person to finger? There have been numerous outbreaks of mumps, measles and pertussis with no initial cases traced to unvaccinated individuals. [See, e.g., Nkowane et al, “Measles Outbreak in a Vaccinated School Population: Epidemiology, Chains of Transmission and the Role of Vaccine Failures,” AJPH April 1987, 77, no. 4.] Presumably, Dr. Caplan would argue no liability should inure to industry because the sale of ineffective or defectively designed vaccines does not constitute negligence.
Dr. Caplan’s interest to hold liable families lawfully exercising religious freedom while letting industry have almost complete liability protection seems peculiarly asymmetrical and unjust. Overall, Dr. Caplan seems to suggest an implied duty to vaccinate on all members of society. Yet the legal foundation for such a duty is shaky, as there is no clear analogue in tort or criminal law for a duty to rescue, even if a person may do so at little or no cost to herself. [See, e.g., Ernest J. Weinrib, The Case for a Duty to Rescue, 90 Yale L.J. 247 (1980) (evaluating the case for imposing a duty to rescue).] If the common law has been unwilling to impose a duty to rescue, Dr. Caplan is likely wrong as a matter of law to suggest that civil liability is a viable work-around for limiting religious vaccination exemptions.
New York State law permits people to refuse vaccines for “genuine and sincere religious beliefs.” [N.Y. Pub. Health Law Section 2164(1)(a) (Consol.2011).] The rationale behind this is that some people have deeply held religious and ethical convictions that conflict with vaccination. Freedom of religion is the first civil right in the First Amendment to the U.S. Constitution; it is the bedrock of U.S. law and culture. Similarly, religious tolerance is a cornerstone of New York State’s historic peace and prosperity. The right to affirm a religious objection to vaccination is part of New York’s heritage. To repeal that, or to subvert it through civil liability, would be to unravel some of the bonds that hold together New York’s extraordinarily diverse society.
Concerns about infectious disease outbreaks are real, however. In the event of an outbreak, unvaccinated children must remain home from school until the outbreak subsides. Such lawful quarantines during public health emergencies respect the rights of all, including the unvaccinated.
Despite sharp disagreement about civil liability, on one important point Dr. Caplan and I agree. He notes in his post that “newborns can’t benefit from vaccines.” Dr. Caplan is correct that there is no compelling science suggesting that newborns’ undeveloped immune systems can benefit from vaccination. Given this acknowledgement, I expect that Dr. Caplan agrees that the federal recommendation that newborns receive the hepatitis B vaccine while still in the hospital is unwise. Dr. Caplan appears to agree that the infant hepatitis B vaccine recommendation and its associated mandates are irrational and violate the Constitution’s 14th amendment equal protection and due process clauses. [See Mary Holland, Compulsory Vaccination, the Constitution, and the Hepatitis B Mandate for Infants and Young Children, 12 Yale J. Health Pol’y L. & Ethics 39 (2012).]
Dr. Bernadine Healy, the late Director of the National Institutes of Health, wrote, “Vaccine policy should be the subject of frank and open debate, with no tolerance for bullying. There are no sides – only people concerned for the well-being of our children.” [book cover blurb, Vaccine Epidemic.] In that spirit, I commend Dr. Caplan for initiating an important debate about civil liability, religious freedom and vaccination.
Mary Holland is Research Scholar and Director of the Graduate Legal Skills Program at NYU Law School. She has published articles on vaccine law and policy, and is the co-editor of Vaccine Epidemic: How Corporate Greed, Biased Science and Coercive Government Threaten Our Human Rights, Our Health and Our Children (Skyhorse Publishing, 2012).